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HSA · registration DE0509353

Barrigel® Applicator Needle

SingaporeGastroenterology & UrologyClass BPallete Life Sciences
Verified
Official record identity
Registration number
DE0509353
Model name
Barrigel® Applicator Needle 3ml
Model identifier
3009-2
Registration date
June 05, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
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Published parties
Product owner
Pallete Life Sciences
Registrant / registration holder
TELEFLEX MEDICAL ASIA PTE. LTD.
Official description

The Barrigel Applicator Needle is designed for injection of Barrigel. The patient contacting portion of the needle is silicone coated, 304 stainless steel. Gamma irradiation is used to sterilize the needle. The Barrigel Applicator Needle is provided in a pouch with two needles.

Additional source fields
Product owner address
27 East Cota St., Suite 402, Santa Barbara, California, 93101, United States
Registrant address
83 CLEMENCEAU AVENUE, #05-05-08, UE SQUARE, Singapore 239920
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.